A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/29/2017 |
| Start Date: | April 2012 |
| End Date: | December 2012 |
An Open-label, Cross-over, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of the Subcutaneous Administration of a Human Plasma-derived C1-esterase Inhibitor in Subjects With Hereditary Angioedema
The aim of the study is to assess what happens to C1-esterase inhibitor that is administered
under the skin of subjects with hereditary angioedema. Three different dosing regimens of
C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3
dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in
the blood will be measured during each 4-week period. The study will also examine how well
C1-esterase inhibitor administered under the skin is tolerated by the subjects.
under the skin of subjects with hereditary angioedema. Three different dosing regimens of
C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3
dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in
the blood will be measured during each 4-week period. The study will also examine how well
C1-esterase inhibitor administered under the skin is tolerated by the subjects.
Inclusion Criteria:
- Males or females aged 18 years or older.
- Laboratory-confirmed hereditary angioedema type I or II.
- Less than two hereditary angioedema attacks per month in the last three months.
- Body weight of 50.0 kg to 110.0 kg.
Exclusion Criteria:
- Receiving prophylactic C1-esterase inhibitor therapy.
- Received C1-esterase inhibitor, ecallantide, icatibant or any blood products for the
prevention or treatment of hereditary angioedema within 7 days before the screening
visit.
- Intends to use recombinant C1-esterase inhibitor or fresh frozen plasma for the acute
treatment of hereditary angioedema during the study.
- Received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone)
within 30 days before the screening visit.
- Female subjects who started taking or changed dose of any hormonal contraceptive
regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing
products) within 3 months prior to the screening visit.
- Known or suspected hypersensitivity to the study product, or to any excipients of the
study product.
- Pregnancy or lactation.
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